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Repurposing generic and off-patent drugs

As healthcare costs around the world continue to rise, regulators are working on developing solutions that will help provide reliable and more affordable treatment options for patients. One such solution is drug repurposing, which involves finding additional uses for already approved drug products.

Because a commercially available drug has already been created, repurposing efforts involve little, if any, discovery and pre-clinical costs. The only major costs incurred by companies are those associated with testing the drug in the new condition in clinical trials, and applying to the relevant regulatory body for approval.

However, drug repurposing is not an attractive prospect for companies when it comes to generic drugs or drugs that have lost their patent protection. For many years, repurposing of these types of drugs has been largely disregarded in Europe. According to a survey conducted by the Commission expert group on safe and timely access to medicines for patients (STAMP), only six out of eighteen participating member states acknowledge repurposing efforts, and only one state was actively exploring potential for collaboration between generic drug producers and academics.

In Europe, repurposing a newly developed branded product can lead to benefits, including tax incentives and years of exclusivity on the market. But, for generic and off-patent products, these incentives do not exist. Without them, pharma companies have little motivation to invest in the repurposing of drugs that provide little return on investment. This is preventing research into new uses for generics, which have the advantage of being known products, with well-documented side-effect profiles. As a result, patients could be missing out on lower-cost treatment options.

Regulators in Europe are starting to respond to this issue and are now making efforts to ensure that repurposing is more of a level playing field across all types of drugs. Early discussions between country regulators and expert groups have been conducted to discuss methods for encouraging increased interest from industry. Providing tax breaks and fee waivers to companies are two potential incentives that have been discussed. There have also been early efforts made to establish relationships between public funders, pharma companies, and academic investigators.

Discussions are still in the early stages, and it may be some time before we hear of any concrete initiatives being put in place. However, it is clear that regulators are at least aware of the issue and are working to find solutions that will improve treatment options for patients.